Could Intralesional Steroid be the Novel Treatment for Granulomatous Mastitis?

NCT04596046 | Completed

• 1 other identifier: 95775
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic granulomatous mastitis (IGM) is a rare, benign inflammatory breast disease that mimics malignancy owing to its features of appearance.In our research, we intended to compare the efficiency of local (intralesional) steroid administration with systemic (peroral) steroid. A total of 36 patients who had been histopathologically diagnosed with IGM and whose other factors had been microbiologically excluded were included in the study. The patients were randomized into two sub-groups that would be treated with systemic and local steroids. Of the patients, 19 were administered with 0.5-1 mg/kg/day peroral systemic steroid, and 17 were administered with 40-200 mg/ml intralesional local steroid regarding the severity of the lesion. All patients were evaluated through physical examination one week after the completion of the treatment. Subsequently, the follow-up of the patients was performed thorough physical examination and ultrasonography and/or magnetic resonance imaging at the 1st, 3rd, and 6th months.

Conditions

Granulomatous Mastitis

Keywords

Idiopathic granulomatous mastitis; intralesional steroid; systemic steroid

Outcome Measures

Primary Outcomes (2)

• Clinical response to the treatment

  Observational evaluation of the changes in terms of inflammation signs (hyperemia, edema, fever)

  6 month

• Changes in the size of the mass

  The area of a mass captured by ultrasonography was calculated in cm\^2 and the change in size was reported as a percentage

  6 month

Study Arms (2)

Group S (systemic-peroral steroid)

ACTIVE COMPARATOR

Medication of oral methylprednisolonewas administered to the patients following the adjustment based on the severity of the lesion and regarding the clinic. The prednisolone dose was 0.5 mg/kg/day in patients with painful, small (\<5.0 cm) unilateral lesions whereas in multiple, bilateral lesions with the diameter of ≥5 cm or for those who had significant cutaneous ulceration, the prednisolone dose was specified as 1 mg/kg/day

Procedure: steroid injecting

Group L (local-intralesional steroid)

EXPERIMENTAL

Triamcinolone acetonidewas administered to the patients through injecting inside the lesion. The practice was based on the dose of TCA administered in acute and chronic inflammatory skin lesions. If the lesion is single-focused and small (\<5.0 cm), 20mg / mL TCA was injected and if the lesion is multifocal or large (\>5.0 cm) then 40mg / mL TCA was injected into the lesion with the guidance of ultrasonography

Procedure: steroid injecting

Interventions

steroid injecting PROCEDURE

Group L: Triamcinolone acetonide was administered to the patients through injecting inside the lesion.Group S: Oral methylprednisolone was administered to the patients.

Group L (local-intralesional steroid); Group S (systemic-peroral steroid)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed with IGM as histopathologically

You may not qualify if:

• Patients who had contraindications with the use of steroids, those with active infections, as well as patients who were pregnant, and who had been diagnosed with breast cancer, were not included in the study.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

emine Yildirim

Gaziosmanpaşa, Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Granulomatous Mastitis

Condition Hierarchy (Ancestors)

Mastitis; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General Surgeon

Model Details: Prospective randomized-controlled study

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: October 22, 2020
• Study Start: November 19, 2019
• Primary Completion: June 15, 2020
• Study Completion: July 17, 2020
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)